Inserter and method for securing an implant to a spinal process with a flexible fastening system

ABSTRACT

A surgical instrument includes a body, a securement arm, a clamp lock, and a tensioning assembly. The body defines a longitudinal axis and has proximal and distal portions. The distal portion defines a recess. The securement arm is coupled to the body and translatable along the body in a direction parallel to the longitudinal axis between first and second position. The clamp lock is pivotally coupled to the distal portion of the body. The clamp lock is pivotable between secured and unsecured configurations. The tensioning assembly translatable in a direction parallel to the longitudinal axis between proximal and distal position. The tensioning assembly configured to draw a flexible band to tension the flexible band about a bony element.

BACKGROUND

1. Technical Field

The present disclosure relates to implants and, more specifically, tomethods, flexible implant systems, and instruments for securing animplant to a bony element.

2. Discussion of Related Art

The spine is made up of a superposition of vertebrae, that are normallyaligned along a vertebral axis, extending from the lumbar vertebrae tothe cervical vertebrae, with each vertebra presenting a posterior wallfrom which a spinous process projects and two side edges having wallsfrom which the ribs and/or transverse processes projects. When anindividual's spine presents abnormal curvature, the vertebrae areinclined relative to one another and relative to said vertebral axis.The lateral edges of the vertebrae situated on one side are thus closerto one another and form a concave curve, while the lateral edges on theother side appear spaced apart from one another and form a convex curve.In order to straighten the spinal column, the lateral edges of thevertebrae on the concave side are spaced apart from one another and aretaken relative to one another to a distance that is substantiallyequivalent to the distance between the lateral edges on the other side.Thereafter, in order to keep the vertebrae in that position relative toone another, known devices are used that have screws for insertion intothe vertebrae or hooks for inserting along the inside wall of the spinalcanal, associated with rods for interconnecting the screws or the hooks.

The hooks are generally inserted in pairs in each vertebra and on eitherside close to the pedicles, the heads of the hooks projecting from theposterior wall of a vertebra, one on either side of the spinous process.The heads may be tulip-shaped to receive a rod that is secured by meansof a set screw inserted in the head and bearing against the rod. Rowsconstituted by the heads of the hooks situated on either side of thespinous processes are interconnected and held in fixed position by tworods that are parallel to each other and to the axis of the spine.

The screws have tulip-shaped heads and are inserted in pairs in theposterior walls of vertebrae in the pedicles on either side of thespinous processes. The screws constitute fastening points in thevertebrae for holding them relative to one another. The screws areinserted into the pedicles of the vertebrae, and under certaincircumstances, the pedicles may be damaged.

Therefore, a continuing need exists for an implant that can address theanatomy correction, including large deformity reductions andtranslations needed, and still maintain the safety of the patient. Inaddition, there is a need for instruments and methods for securing suchan implant to a bony element of a patient.

SUMMARY

In an aspect of the present disclosure, a surgical instrument includes abody, a securement arm, a clamp lock, and a tensioning assembly. Thebody defines a longitudinal axis and has proximal and distal portions.The distal portion defines a recess. The securement arm is coupled tothe body and is translatable along the body in a direction parallel tothe longitudinal axis between first and second positions. The clamp lockis pivotally coupled to the distal portion of the body. The clamp lockis pivotable between secured and unsecured configurations. Thetensioning assembly is translatable in a direction that is parallel tothe longitudinal axis between proximal and distal positions. Thetensioning assembly is configured to draw a flexible band to tension theflexible band about a bony element.

In aspects, the surgical instrument includes a securement screw thatpasses through a securement opening defined in the proximal portion ofthe body. The securement screw may be rotatably coupled to a distal endof the securement arm and may be configured to translate the securementarm between its first and second positions. The securement screw mayinclude a threaded body and the walls that define the securement openingmay include threads. The threaded body of the securement screw mayengage the threads of the securement opening such that the securementarm translates in a direction that is parallel to the longitudinal axisin response to rotation of the securement screw. The securement arm mayinclude securement fingers that define a passage therebetween. Thedistal portion of the body may be positioned within the passage.

In some aspects, the clamp lock includes a securement tab that ispositioned on one end and defines a lock cam opening on the other end.The clamp lock may define a pivot pin opening positioned between thesecurement tab and the lock cam opening. The pivot pin opening mayreceive a pivot pin that is fixed to the distal portion of the body suchthat the clamp lock is pivotable about the pivot pin. The securement tabmay be configured to engage a notch defined by a clamp received withinthe recess defined in the distal portion of the body to secure the clampwithin the recess. The lock cam opening may receive a lock cam pin. Thesecurement arm may include securement fingers where each securementfinger defines a lock cam channel. The lock cam pin may be disposedwithin the lock cam channel of each of the securement fingers. In theproximal position of the securement arm, the walls defining the lock camchannels may engage the lock cam pin to secure the clamp lock in itssecured configuration. In the distal position of the securement arm, thewalls defining the lock cam channels may engage the lock cam pin topivot the clamp lock to its unsecured position. The securement arm mayhave an intermediate position between its first and second position suchthat the clamp lock is pivotable between its secured and unsecuredpositions. The clamp lock may be biased towards the securedconfiguration.

In particular aspects, the surgical instrument includes a tensioningscrew that passes through a tensioning opening defined in the proximalportion of the body. The tensioning screw may pass through a tensioningbody of the tensioning assembly and may be configured to translate thetensioning assembly between the proximal and distal positions. Thedistal portion of the body may include a tensioning screw support armthat extends perpendicular to the longitudinal axis and defines atensioning screw securement opening that rotatably receives a distal endof the tensioning screw.

In certain aspects, the tensioning assembly includes a button thatdefines a tensioning screw passage which receives a threaded body of thetensioning screw therein. The tensioning screw passage may be defined bya first wall that has a smooth surface and a second wall that includesthreads. The button may have a disengaged position in which the secondwall is engaged with the threaded body of the tensioning screw such thatthe tensioning assembly translates in a direction that is parallel tothe longitudinal axis in response to rotation of the tensioning screw.The button may have a depressed position in which the second wall isdisengaged from the threaded body of the tensioning screw such that thetensioning assembly is freely translatable over the threaded bodyparallel to the longitudinal axis irrespective of rotation of thetensioning screw. The tensioning assembly may include a button biasingmember that is positioned to urge the button towards the disengagedposition.

In aspects, the surgical instrument includes a band locking mechanismthat is positioned on the tensioning assembly. The band lockingmechanism may be configured to fix a flexible band to the tensioningassembly. The tensioning assembly may include first and second supportarms. Each of the first and second support arms may define a pin openingthat receives an end of the flexible band lock pivot pin. The bandlocking mechanism may include a locking lever that is pivotallysupported about the flexible band lock pivot pin. The band lockingmechanism may include an inner locking member and an outer lockingmember. The inner locking member may be pivotally coupled to atensioning body of the tensioning assembly and may include an innerlocking surface that faces the outer locking member. The outer lockingmember may include tabs that are connected by a connector. Each of thetabs may define a flexible band pin lock opening that slidably receivesthe band locking pin. The tabs may define opposing camming recesses thatare configured to receive cam bosses defined on the locking lever. Thelocking lever may be pivotable between unlocked and lockedconfigurations. As the locking lever is pivoted towards the lockedconfiguration, the cam bosses may engage the tabs to move an outerlocking surface, that is disposed on the outer locking member, towardsthe inner locking surface. The inner and outer locking surfaces maydefine a band passage therebetween and may be configured to fix aflexible band within the band passage when the locking lever is in itslocked configuration.

In some aspects, the recess defined by the distal portion of the body isconfigured to receive a clamp. The securement arm may be configured tosecure a rod within a clamp that is received in the recess defined bythe distal portion of the body. In the secured configuration of theclamp lock, the clamp lock may be configured to secure a clamp withinthe recess defined by the distal portion of the body. The tensioningassembly may be configured to draw the flexible band through a clampthat is secured in the recess of the distal portion defining by thedistal portion of the body.

In another aspect of the present disclosure, a method of surgeryincludes positioning a clamp within a recess defined in a distal portionof a body of a surgical instrument, positioning a rod within a rodcavity defined by the clamp, rotating a securement screw of the surgicalinstrument to translate a securement arm of the surgical instrumentdistally, passing ends of a flexible band that is positioned about abony element through a slot of the clamp and through a band passagedefined by a band locking mechanism of the surgical instrument, rotatinga band locking lever of the band locking mechanism to a lockedconfiguration to fix the flexible band within the band passage, rotatinga tensioning screw to translate the locking mechanism proximally overthe tensioning screw parallel to the longitudinal axis to tension theflexible band about the bony element, securing the clamp to the rod,securing the clamp to the flexible band, and releasing the clamp fromthe recess of the distal portion of the surgical interment. The body ofthe surgical instrument defines a longitudinal axis. The securementfingers of the securement arm may secure the rod within the rod cavityof the clamp when the securement arm is translated distally.

In aspects, positioning the clamp within the recess includes urging aclamp lock towards an unsecured configuration with the clamp as theclamp is positioned within the recess. The clamp lock may engage theclamp to secure the clamp within the recess when the clamp is positionedwithin the recess. Positioning the clamp within the recess may includerotating the securement screw to translate the securement arm to a fullyproximal position. The securement arm may define lock cam channels thateach have walls which engage a lock cam pin to pivot a clamp lock to anunsecured configuration. Rotating the securement screw may includepivoting the clamp lock to a secured configuration to secure the clampwithin the clamp recess in response to distal translation of thesecurement arm. During subsequent distal translation of the securementarm, the wall defining the lock cam channel may engage the lock cam pinto fix the clamp lock in the secured configuration.

In some aspects, the method includes inserting a tool through an openingin the distal portion to engage a rod set screw to the clamp androtating the tool such that the rod set screw is rotated to partiallysecure the rod within the rod cavity of the clamp after rotating thesecurement screw of the surgical instrument to translate the securementarm of the surgical instrument and before passing ends of the flexibleband through the slot of the clamp. Securing the clamp to the rod mayinclude inserting a tool through an opening in the distal portion toengage a rod set screw of the clamp and rotating the tool such that therod set screw is rotated to secure the rod within the rod cavity of theclamp.

In particular aspects, the method includes depressing a button of atensioning assembly and translating the tensioning assembly proximallyover the tensioning screw to a distal position before rotating the bandlocking lever of the band locking member to the locked configuration.The method may include rotating the tensioning screw to translate thelocking mechanism to a distal position before pivoting the band lockinglever of the band locking member to the locked configuration.

In certain aspects, rotating the band locking lever includes engaging anouter locking member with camming bosses of the band locking lever tomove the outer locking member towards an inner locking member. The bandpassage may be defined between locking surfaces of the inner and outerlocking members. Securing the clamp to the flexible band may includeinserting a tool through an opening in the distal portion to engage aband set screw of the clamp and rotating the tool such that the band setscrew is rotated to secure the flexible band within the rod cavity ofthe clamp. Releasing the clamp may include rotating the securement screwto translate the securement arm to a fully proximal position. Thesecurement arm may define lock cam channels that have walls which engagea lock cam pin to pivot a clamp lock to an unsecured configuration. Themethod may include trimming the flexible band to length adjacent theclamp after securing the flexible band to the clamp.

Further, to the extent consistent, any of the aspects described hereinmay be used in conjunction with any or all of the other aspectsdescribed herein.

BRIEF DESCRIPTION OF THE DRAWINGS

Various aspects of the present disclosure are described hereinbelow withreference to the drawings, which are incorporated in and constitute apart of this specification, wherein:

FIG. 1 is a perspective view of an inserter provided in accordance withthe present disclosure;

FIG. 2 is an exploded perspective view, with parts separated, of theinserter of FIG. 1;

FIG. 3 is an enlarged view, with parts separated, of the indicated areaof detail of FIG. 2;

FIG. 4 is a rear perspective view, with parts separated, of thetensioning assembly of FIG. 3;

FIG. 5 is a side view of the inserter of FIG. 1 in with a securement armof the inserter in an intermediate position and an clamp positionedbelow a clamp recess of the inserter;

FIG. 6 is a side view of the inserter of FIG. 1 with the clamppositioned within the clamp of the inserter and the securement arm ofthe inserter in a proximal position such that a clamp lock is in anunsecured configuration;

FIG. 7 is a side view of the inserter of FIG. 6 with a flexible banddrawn through the clamp, the securement arm of the inserter in theintermediate position, and the clamp lock in a secured configuration;

FIG. 8 is a side view of the inserter of FIG. 7 with a rod received inthe clamp;

FIG. 9 is a side view of the inserter of FIG. 8 in with the securementarm in a distal position;

FIG. 10 is a side view of the inserter of FIG. 9 with a tool insertedthrough the inserter to partially secure the clamp to the rod;

FIG. 11 is a side view of the inserter of FIG. 9 with the flexible banddrawn through a band passage of a band locking mechanism which is in anunlocked configuration and a tensioning assembly in a proximal position;

FIG. 12 is a side view of the inserter of FIG. 11 with the tensioningassembly in a distal position;

FIG. 13 is a side view of the inserter of FIG. 12 with the band lockingmechanism in a locked configuration;

FIG. 14 is a side view of the inserter of FIG. 13 with the tensioningassembly translated to the proximal position with the flexible bandfixed to the tensioning assembly;

FIG. 15 is a side view of the inserter of FIG. 14 with a tool insertedthrough the inserter to fix the flexible band to the clamp; and

FIG. 16 is a side view of the inserter of FIG. 15 released from theclamp and the flexible band trimmed to length.

DETAILED DESCRIPTION

Embodiments of the present disclosure are now described in detail withreference to the drawings in which like reference numerals designateidentical or corresponding elements in each of the several views. Ascommonly known, the term “clinician” refers to a doctor, a nurse or anyother care provider and may include support personnel. Additionally, theterm “proximal” refers to the portion of the device or component thereofthat is closer to the clinician and the term “distal” refers to theportion of the device or component thereof that is farther from theclinician. In addition, the term “cephalad” is known to indicate adirection toward a patient's head, whereas the term “caudal” indicates adirection toward the patient's feet. Further still, the term “lateral”is understood to indicate a direction toward a side of the body of thepatient, i.e., away from the middle of the body of the patient. The term“posterior” indicates a direction toward the patient's back, and theterm “anterior” indicates a direction toward the patient's front.Additionally, terms such as front, rear, upper, lower, top, bottom, andsimilar directional terms are used simply for convenience of descriptionand are not intended to limit the disclosure. In the followingdescription, well-known functions or constructions are not described indetail to avoid obscuring the present disclosure in unnecessary detail.

This disclosure relates generally to an instrument and method forsecuring a flexible implant system to a bony element of a patient. Theflexible implant system includes a clamp and a flexible band that wrapsaround a bony element. The instrument secures to the clamp such that aclinician may draw the flexible band through the clamp and secure theclamp to a rod. Then, the clinician uses the instrument to tension theflexible band about the bony element and to fix the flexible band to theclamp. For a detailed description of a suitable implant or clamp,reference may be made to commonly owned U.S. Patent ApplicationPublication No. 2014/0257397, the entire contents of this applicationare hereby incorporated by reference.

Referring now to FIGS. 1 and 2, a surgical instrument or inserter 10 isprovided in accordance with the present disclosure and includes a body20, a securement arm 40, a clamp lock 50, a tensioning assembly 60, asecurement screw 80, and a tensioning screw 90. The body 20 includes aproximal portion 22, a central portion 24 extending from the proximalportion 22, and a distal portion 30 extending from the central portion24. The central portion 24 defines a longitudinal axis A-A. The proximalportion 22 is substantially rectangular in cross-section and isorthogonal to the longitudinal axis A-A with first and second endsextending beyond the central portion 24. The first end defines asecurement screw opening 88 that extends parallel to the longitudinalaxis A-A and that is threaded to cooperate with threads of thesecurement screw 80 as detailed below. The second end defines atensioner screw opening 98 that extends parallel to the longitudinalaxis A-A and that is dimensioned to allow the tensioning screw 90 tofreely rotate relative to the proximal portion 22. The central portion24 includes central arm guides 26 and the distal portion 30 includesdistal arm guides 28 positioned on opposite sides of the body 20parallel to the longitudinal axis A-A.

The distal portion 30 receives and secures an implant or clamp 12 (FIG.5) to the inserter 10. The distal portion 30 defines a clamp receiver 32that is dimensioned and shaped to receive the clamp 12. The distalportion 30 includes an alignment tab 36 for engaging a correspondingalignment notch 14 defined by the clamp 12 to align the clamp 12 withthe clamp receiver 32. The distal portion 30 also defines tool openings34 a, 34 b that extend through the distal portion 30 and into the clampreceiver 32 (FIG. 5). The tool openings 34 a, 34 b extend parallel toone another and are offset from the longitudinal axis A-A by an angle θ(FIG. 10) to provide clearance for a tool as detailed below. The angle θmay be in a range of about 15° to about 45° (e.g., about 30°). The toolopenings 34 a, 34 b are sized to receive tools for manipulating theclamp 12 secured in the clamp receiver 32 as detailed below.

The securement arm 40 is slidable relative to the body 20 to lock theclamp 12 within the clamp receiver 32 and retain a rod 19 (FIG. 8)within the clamp 12 as detailed below. The securement arm 40 includes aproximal end portion 42, an arm body 44, and distal securement fingers46. The proximal end portion 42 defines a securement screw opening 43that receives a distal retainer 86 of the securement screw 80 asdetailed below. The arm body 44 extends from the proximal end portion 42parallel to the longitudinal axis A-A. The proximal end portion 42 andthe arm body 44 define a guide channel 45 that slidably receives centraland distal arm guides 26, 28 of the body 20. The securement fingers 46extend from the arm body 44 and define a passage 49 therebetween. Thesecurement fingers 46 are positioned on either side of the distalportion 30 of the body 20 such that the distal portion 30 is positionedwithin the passage 49. Each of the securement fingers 46 also defines aguide shelf 47 that slides along surfaces of the distal guides 28 of thedistal portion 30. Each retention arm 46 also defines a lock cam channel48 that receives a lock cam pin 54. As discussed in greater detailbelow, the lock cam channel 48 engages the lock cam pin 54 as thesecurement arm 40 is translated to pivot the clamp lock 50 such that theclamp 12 is within the clamp receiver 32 of the distal portion 30.

The securement screw 80 is rotatable to translate the securement arm 40parallel to the longitudinal axis A-A of the inserter 10 between a firstor proximal position (FIG. 6), an intermediate position (FIG. 8), and asecond or distal position (FIG. 9). The securement screw 80 includes ahead 81, a threaded body 84, and a distal retainer 86. The head 81includes a tool engagement portion 82 proximal to a finger engagementportion 83. The tool engagement portion 82 is dimensioned and shaped tobe engaged by a tool (not explicitly shown) to rotate the securementscrew 80. For example, the tool engagement portion 82 may define arecess that is engagable with a torx or star-shaped screwdriver.Additionally or alternatively, the tool engagement portion 82 may have ahexagonal outer surface that is engagable with a wrench or a socket. Thefinger engagement portion 83 is sized and shaped to be engaged byfingers of a clinician to rotate the securement screw 80. For example,the finger engagement portion 83 may include a knurled outer surface.Additionally or alternatively, the outer surface of the fingerengagement portion 83 may include a plurality of raised surfaces withgrooves between the raised surfaces to provide a gripping surface forfingers of a clinician.

The threaded body 84 of the securement screw 80 extends distally fromthe head 81 parallel to the longitudinal axis A-A. The distal retainer86 is spaced apart from the threaded body 84 to define a retentionrecess 85 between the threaded body 84 and the distal retainer 86. Thethreaded body 84 passes through and cooperates with threads on the innersurface of the securement screw opening 88 defined in the proximalportion 22 of the body 20. A portion of the head 81 (e.g., fingerengagement portion 83) is larger than the threaded body 84 to preventthe securement screw 80 from passing entirely through the securementscrew opening 88. The distal retainer 86 passes through the securementscrew opening 43 defined in the proximal end portion 42 of thesecurement arm 40. The proximal end portion 42 defines openings 41 athat receive retention pins 41. Each of the retention pins 41 passthrough the retention recess 85 of the securement screw 80 such that thesecurement screw 80 passing between the retention pins 41 to rotatablyreceive and longitudinally fix the distal retainer 86 of the securementscrew within the proximal end portion 42 of the securement arm 40. Thus,allowing the securement screw 80 to rotate relative to the securementarm 40 such that as the securement screw 80 is rotated, the securementscrew 80 translates the securement arm 40 between its proximal anddistal positions as detailed below.

With continued reference to FIG. 2, the clamp lock 50 engages the clamp12 to secure the clamp 12 (FIG. 6) in the clamp receiver 32 of thedistal portion 30. A proximal end of the clamp lock 50 defines a lockcam opening 55 and a distal end of the clamp lock 50 includes a lockingtab 59 facing the clamp receiver 32. The clamp lock 50 defines a pivotpin opening 57 between the lock cam opening 55 and the locking tab 59.The distal portion 30 defines a pivot pin passage 58 that receives apivot pin 56 which passes through the pivot pin opening 57 of the clamplock 50 to pivotally secure the clamp lock 50 to the distal portion 30of the body 20.

The clamp lock 50 is pivotable between a secured configuration (FIG. 5)and an unsecured configuration (FIG. 6). In the secured configuration,the locking tab 59 of the clamp lock 50 is positioned to engage a notch16 of the clamp 12 to secure the clamp 12 within the clamp receiver 32.In the unsecured configuration, the locking tab 59 is positioned awayfrom the clamp 12 such that the clamp 12 is moveable into or out of theclamp receiver 32. The clamp lock 50 may include a lock biasing member51 positioned between the distal portion 30 and the clamp lock 50 thatengages the clamp lock 50 between the pivot pin opening 57 and the lockcam opening 55 to urge the clamp lock 50 towards the secured position.The clamp lock 50 may define a recess for receiving an end of the lockbiasing member 51. The distal portion 30 may also define a cam notch 35that receives the cam pin 54 when the clamp lock 50 is in the unsecuredposition.

With additional reference to FIG. 3, the tensioning assembly 60 issecured to a flexible band 18 (FIG. 11) to tension the flexible band 18about a bony element as the tensioning screw 90 is rotated as detailedbelow. The tensioning assembly 60 includes a tensioning body 62, abutton 64, and a band locking mechanism 70. The tensioning body 62defines a tensioning screw channel 142 that passes through thetensioning body 62 parallel to the longitudinal axis A-A when theinserter 10 is assembled. A surface 62 c of the tensioning body 62facing the central portion 22 of the body 20 of the inserter 10 includesa guide nub 148 that is slidably received within a tensioner guidechannel 27 (FIG. 1) defined in a surface of the central portion 22 ofthe body 20 facing the tensioning assembly 60. The tensioning body 62also defines a button well 146 in one side surface 65 a that passesthrough the majority of the tensioning body 62 orthogonal to and throughthe tensioning screw channel 142 that is sized to receive the button 64.A button ring 144 may extend from this side surface 62 a of thetensioning body 62 around the outer perimeter of the button well 146. Asshown in FIG. 4, the opposite side surface 62 b of the tensioning body62 may define an extension opening 155 that is axially aligned with thebutton well 146.

With continued reference to FIG. 3, the button 64 has a substantiallycylindrical body 151 and includes a button extension 154 that extendsfrom one end of the cylindrical body 151. The button extension 154 has adiameter that is less than the diameter of the cylindrical body 151. Theother end of the cylindrical body 151 includes defines an engagementsurface 156. The cylindrical body 151 defines a tensioning screw passage152 that passes through the cylindrical body 151 at a location betweenthe button extension 154 and the engagement surface 156. The tensioningscrew passage 152 defines an oblong shape and is larger than thetensioning screw 90 (FIG. 2). The tensioning screw passage 152 isdefined by a first wall or clearance 153 a that has a substantiallysmooth surface and a second wall 153 b that is threaded to engagethreads of the tensioning screw 90 as detailed below. The first wall 153a is positioned adjacent the engagement surface 156 of the button 64 andthe second wall 153 b is positioned adjacent the button extension 154.As shown, each of the first and second walls 153 a, 153 b define half ofthe tensioning screw passage 152; however, it is contemplated that oneof the first or second walls 153 a, 153 b may define more than half(e.g., 75%) of the tensioner screw passage 152 with the other one of thefirst or second walls 153 a, 153 b defining the remainder (e.g., 25%) ofthe tensioning screw passage 152.

The button 64 is positioned within the button well 146 of the tensioningbody 62 with a button biasing member 66 positioned about the buttonextension 154 between the cylindrical body 151 and the side surface 62 bof the body 62 such that the button 64 is biased out of the button well146. As shown, the button biasing member 66 is in the form of a seriesof stacked Belleville washers; however, other biasing members are alsocontemplated including, but not limited to, coil springs. As discussedin detail below, the tensioning screw 90 passes through the tensioningscrew channel 142 of the tensioning body 62 and the tensioning screwpassage 152 of the button 64 to retain the button 64 within the buttonwell 146.

The button 64 has a disengaged position (FIG. 1) and a depressedposition (FIG. 12). In the disengaged position, the button biasingmember 66 urges the threads of the second wall 153 b into engagementwith a threaded body 94 of the tensioning screw 90. In the depressedposition, the button 64 is depressed against the button biasing member66 such that the threads of the second wall 153 b are disengaged fromthe threaded body 94 of the tensioning screw 90. In the depressedposition, the button extension 154 may be positioned within theextension opening 155 to provide enough clearance for the second wall153 b to disengage the threaded body 94. Further, in the depressedposition, the first wall 153 a may abut the threaded body 94 of thetensioning screw 90.

The tensioning screw 90 includes a head 91, the threaded body 94, and adistal retainer 96. The head 91 includes a tool engagement portion 92proximal to a finger engagement portion 93. The tool engagement portion92 is dimensioned and shaped to be engaged by a tool (not explicitlyshown) to rotate the tensioning screw 90. For example, the toolengagement portion 92 may define a recess that is engagable with a torxor star-shaped screwdriver. Additionally or alternatively, the toolengagement portion 92 may have a hexagonal outer surface that isengagable with a wrench or a socket. The finger engagement portion 93 issized and shaped to be engaged by fingers of a clinician to rotate thetensioning screw 90. For example, the finger engagement portion 93 mayinclude a knurled outer surface. Additionally or alternatively, theouter surface of the finger engagement portion 93 may include aplurality of raised surfaces with grooves between the raised surfaces toprovide a gripping surface for fingers of a clinician.

The threaded body 94 of the tensioning screw 90 extends distally fromthe head 91 parallel to the longitudinal axis A-A (FIG. 2). The distalretainer 96 is spaced apart from the threaded body 94 to define aretention recess 95 between the threaded body 94 and the distal retainer96. The threaded body 94 passes through the tensioning screw opening 98defined in the proximal portion 22 of the body 20. The tensioning screwopening 98 is sized to permit the threaded body 94 of the tensioningscrew 90 to rotate freely. A portion of the head 91 (e.g., fingerengagement portion 93) is larger than the threaded body 94 to preventthe tensioning screw 90 from passing entirely through the tensioningscrew opening 98.

Referring briefly back to FIG. 2, the distal portion 30 includes atensioning screw securement arm 37 that extends orthogonal to thelongitudinal axis A-A (FIG. 2). The tensioning screw securement arm 37also defines a tensioning screw securement opening 39 that is alignedwith the tensioning screw opening 98 defined in the proximal portion 20.The distal retainer 96 of the tensioning screw 90 passes through thetensioning screw securement opening 39 defined in the tensioning screwsecurement arm 37 of the distal portion 30. Each of the retention pins61 pass through the retention recess 95 of the tensioning screw 90 suchthat the tensioning screw 90 passes between the retention pins 61 torotatably receive and longitudinally fix the distal retainer 96 of thetensioning screw 90 within the tensioning screw securement arm 37 of thedistal portion 30. Thus, allowing the tensioning screw 90 to rotaterelative to the tensioning screw securement arm 37. As detailed below asthe tensioning screw 90 is rotated, the tensioning screw 90 translatesthe tensioning assembly 60 parallel to the longitudinal axis A-A (FIG.2) between a proximal position (FIG. 14) and a distal position (FIG.12).

With reference to FIGS. 3 and 4, the band locking mechanism 70 secures aflexible band 18 (FIG. 7) to the tensioning assembly 60 such that thetensioning assembly 60 may draw the flexible band 18 through the clamp12 to tension the flexible band 18 about a bony element as detailedbelow. The band locking mechanism 70 includes band locking lever 74, anouter locking member 76, and an inner locking member 78. First andsecond support arms 160 a, 160 b support the band locking lever 74 andthe outer locking member 76 to the tensioning body 62. The first supportarm 160 a is fixed to the side surface 62 b of the tensioning body 62opposite the side surface 62 a that defines the button well 146. Thefirst support arm 160 a extends past a surface 62 d of the tensioningbody 62 and away from the surface 62 c of the tensioning body 62, whichincludes the guide nub 148, such that the first support arm 160 aextends away from the body 20 of the inserter 10. The first support arm160 a extends orthogonal to the body 20 of the inserter 10. The secondsupport arm 160 b is spaced apart from the first support arm 160 a andis supported by a bridge 163 that extends from the first support arm 160a. The second support arm 160 b and the bridge 163 define a band passage168 with a surface of the tensioning body 62 opposite the guide nub 148.The first support arm 160 a may act as a back stop to the band passage168 as detailed below.

The first and second support arms 160 a, 160 b define a lock channel 162therebetween. The first and second support arms 160 a, 160 b each definea lock guide channel 164 in a surface opposing the other support arm 160a, 160 b that is orthogonal to the band passage 168 and in communicationwith the lock channel 162. Each of the first and second support arms 160a, 160 b also defines a pin opening 166 that passes through the lockchannel 162. The pin openings 166 oppose ends that receive an end of aband lock pivot pin 72. As detailed below, the band lock pivot pin 72supports the band locking lever 74 and the outer locking member 76.

The band locking lever 74 defines a pin opening 172 and includes a leverarm 170, cam bosses 174, and a camming surface 176. The pin opening 172is sized to rotatably receive the band lock pivot pin 72 therethrough tosupport the band locking lever 74. The lever arm 170 extends from thepin opening 172. The cam bosses 174 are positioned adjacent the pinopening 172 and extend parallel to an axis defined by the pin opening172. The camming surface 176 is disposed on an outer surface of the bandlocking lever 74 about the pin opening 172.

The outer locking member 76 includes tabs 178 that are joined by aconnector 183 and define a lever channel 179 therebetween. The tabs 178extend parallel to one another and in the same direction from theconnector 183. Each of the tabs 178 defines a pin slot 182 that slidablyreceives the band locking pin 72 such that each tab 178 is positionedbetween the band locking lever 74 and a respective one of the first andsecond support arms 160 a, 160 b. Each of the tabs 178 includes a slide180 that is positioned along one side of the pin slot 182 and extendstowards the respective one of the first and second support arms 160 a,160 b. Each slide 180 is slidably received in the lock guide channel 164defined in the respective one of the first and second support arms 160a, 160 b. The slides 180 of the outer locking member 76 are slidablewithin the lock guide channels 164 such that the outer locking member 76is slidable towards and away from the surface 62 d of the tensioningbody 62.

The band locking lever 74 is rotatable about the band locking pin 72 tomove the outer locking member 76 towards and away from the surface 62 dof the tensioning body 62. Each of the tabs 178 defines the band lockingslot 182 that slidably receive the band locking pin 72. Tabs 178 alsodefine camming recesses 181 that oppose one another. The cammingrecesses 181 are in communication with the lever channel 179 and aredefined in an inner surface of each of the tabs 178 opposite the slides180. Each of the camming recesses 181 receives one of the cam bosses 174of the band locking lever 74 to move the outer locking member 76 towardsand away from the tensioning body 62 in response to rotation of the bandlocking lever 74 as detailed below. Walls defining the camming recesses181 may also limit the rotation of the band locking lever 74 about theband locking pin 72. The connector 183 includes a textured lockingsurface 184 that faces the tensioning body 62 and that is positionedwithin the band passage 168. The textured locking surface 184 mayinclude a plurality of protrusions that engage a flexible band 18 (FIG.11) disposed within the band passage 168 as discussed in greater detailbelow.

With continued reference to FIGS. 3 and 4, the inner locking member 78includes a textured locking surface 189 that is positioned within theband passage 168 and in opposition to the textured locking surface 184of the outer locking member 78. The textured locking surface 189 issubstantially similar to the textured locking surface 184 of the outerlocking member 76. The inner locking member 78 is pivotally coupled tothe tensioning body 62 by a protrusion 186 that extends from thetextured locking surface 189 towards the tensioning body 62.

The protrusion 186 defines a retention opening 188 that receives aretention screw 68 therethrough to fix the inner locking member 78 tothe tensioning body 62. The tensioning body 62 defines an opening 185 inthe surface 62 d that receives the protrusion 186 of the inner lockingmember 78. With particular reference to FIG. 4, the tensioning body 62defines a retention screw opening 149 that passes through the opening185. A portion of the retention screw opening 149 is threaded. Theretention screw 68 is threaded through the retention screw opening 149and passes through the retention opening 188 of the inner locking member78 to secure the inner locking member 78 within the opening 185 of thetensioning body 62. The retention screw opening 149 may also passthrough the first support arm 160 a.

The locking mechanism 70 is moveable between an unlocked configuration(FIG. 12) and a locked configuration (FIG. 13). In the lockedconfiguration, the lever arm 170 of the locking lever 74 issubstantially parallel to the longitudinal axis A-A (FIG. 2) such thatthe locking mechanism 70 engages a flexible band 18 disposed within theband passage 168 between the locking surfaces 184, 189 of the inner andouter locking members 76, 78, respectively, to fix the flexible band 18relative to the tensioning body 62. In the unlocked configuration, thelever arm 170 of the locking lever 74 is substantially perpendicular tothe longitudinal axis of the inserter 10 such that a flexible band 18 isslidable through the band passage 168 between the locking surfaces 184,189 of the inner and outer locking members 76, 78, respectively. As theband locking lever 74 is rotated about the band locking pin 72 towardsthe unlocked configuration, the cam bosses 174 of the band locking lever74 engage the outer locking member 76 to move the outer locking member76 away from the tensioning body 62 such that the locking surface 184 ofthe outer locking member 76 is moved away from the locking surface 189of the inner locking member 78. As the band locking lever 74 is rotatedtowards its locked configuration, the cam bosses 174 engage the outerlocking member 76 to move the outer locking member 76 towards thetensioning body 62 such that the locking surface 184 of the outerlocking member 76 is moved towards the locking surface 189 of the innerlocking member 78. Additionally, the camming surface 176 of the bandlocking lever 74 may engage the connector 183 of the outer lockingmember 76 as the band locking lever 74 is rotated towards its lockedconfiguration to move the outer locking member 76 towards the tensioningbody 62.

Referring now to FIGS. 5-16, a method of securing a flexible implantsystem to a bony element with an inserter is disclosed in accordancewith the present disclosure. Initially, with reference to FIG. 5, theinserter 10 is positioned over the clamp 12 of a flexible implant systemsuch that the clamp 12 is adjacent the clamp receiver 32 of the distalportion 30 with the securement arm 40 in the intermediate positionbetween the proximal and distal positions such that the clamp lock 50 ispivotable between its secured and unsecured configurations. The inserter10 is aligned with the clamp 12 such that the upper surface of the clamp12 is positioned towards the clamp receiver 32 which is sized and shapedto receive the upper surface of the clamp 12. In such an unsecuredposition of the clamp lock 50, the lock cam pin 54 is moveable withinthe lock cam channel 48 defined in each of the securement fingers 46 ofthe securement arms 40.

With particular reference to FIG. 6, the inserter 10 is moved onto theclamp 12 such that the upper surface of the clamp 12 is received withinthe clamp receiver 32 of the distal portion 30. The securement screw 80is rotated in a first direction to move the securement arm 40 to itsproximal position such that the lock cam pin 54 is engaged by walls ofthe lock cam channel 48 to move the clamp lock 50 to its unsecuredconfiguration. It is contemplated that the securement fingers 46 mayinclude visual indicia (e.g., a groove 46 a in an outer surface of thesecurement fingers 46) to indicate when the securement arm 40 is in theintermediate position. In the intermediate position, the lock cam pin 54is engaged with walls defining the lock cam channel 48 such thatsubsequent proximal movement of the securement arm 40 will move theclamp lock 50 towards its unsecured configuration. In the unsecuredconfiguration of the clamp lock 50, the lock cam pin 54 is positionedwithin the cam notch 35 of the distal portion 30. As the distal portion30 engages the clamp 12, the alignment tab 36 of the distal portion 30engages an alignment notch 14 of the clamp 12 to align the clamp 12 withthe distal portion 30.

Referring now to FIG. 7, the securement screw 80 is rotated in a seconddirection opposite the first direction to move the securement arm 40towards its secured position until the clamp lock 50 returns to thesecured configuration such that the locking tab 59 of the clamp lock 50engages the securement notch 16 of the clamp 12 to secure the clamp 12in the clamp receiver 32 of the distal portion 30. The locking tab 59may provide audible indicia when it engages the securement notch 16.

It is contemplated that the clamp 12 may be secured in the clampreceiver 32 without the securement arm 40 in the unsecured position. Forexample, with the securement arm 40 in the intermediate position asshown in FIG. 5, as the distal portion 30 engages the clamp 12, theclamp 12 may engage the locking tab 59 of the clamp lock 50 to pivot theclamp lock 50 towards the unsecured configuration against the lockbiasing member 51 (FIG. 2) until the securement notch 16 of the clamp 12is aligned with the locking tab 59. When the securement notch 16 of theclamp 12 is aligned with the locking tab 59, the lock biasing member 51urges the locking tab 59 into the securement notch 16 to secure theclamp 12 within the clamp receiver 32 of the distal portion 30.

With continued reference to FIG. 7, when the clamp 12 is secured to theinserter 10, ends 18 a of a flexible band 18, that is wrapped about abony element VB, are passed through a slot (not explicitly shown) of theclamp 12. The ends 18 a of the flexible band 18 are stacked on top ofone another as the flexible band 18 is passed through the slot of theclamp 12.

Referring to FIG. 8, with the flexible band 18 within the slot of theclamp 12, the inserter 10 is used to position a rod 19 (e.g., a spinalrod) within a rod cavity 17 defined by the clamp 12. The clamp 12 mayprovide audible indicia (e.g., a click) when the rod 19 is receivedwithin the rod cavity 17. The ends 18 a of the flexible band 18 may beheld or pulled as the rod 19 is positioned within the rod cavity 17 todraw slack, excess material, of the flexible band 18 through the slot ofthe clamp 12.

With reference to FIG. 9, with the rod 19 positioned within the rodcavity 17 of the clamp 12, the securement screw 80 is rotated in thesecond direction to move the securement arm 40 towards its distalposition. As the securement arm 40 moves towards its distal position,the securement fingers 46 engage the rod 19 to secure the rod 19 withinthe rod cavity 17 of the clamp 12 to prevent the rod 19 from moving outof the rod cavity 17 while allowing clamp 12 to slide over the rod 19until the clamp is locked to the rod 19 as detailed below. Further, asthe securement arm 40 moves towards its distal position, the lock camchannel 48 moves over the lock cam pin 54 such that the walls definingthe lock cam channel 48 engage the lock cam pin 54 to prevent the clamplock 50 from pivoting towards the unsecured configuration (FIG. 6). Assuch, when the securement arm 40 is in its distal position, the clamp 12is fully secured in the clamp cavity 32 of the distal portion 30 and therod 19 is secured in the rod cavity 17 of the clamp 12.

Referring to FIG. 10, with the securement arm 40 in its distal position,a tool 200 may be inserted through the tool opening 34 b of the distalportion 30 to engage a rod set screw 13 of the clamp 12. The tool 200 isrotated to rotate the rod set screw 13 into engagement with the rod 19to partially secure the clamp 12 to the rod 19. The rod set screw 13 isonly partially tightened to permit the clamp 12 to move about the rod 19(e.g., rotate) as the flexible band 18 is fully tensioned about the bonyelement VB as detailed below. Once the rod 19 is partially securedwithin the clamp 12, the tool 200 is removed from the tool opening 34 b.

With reference to FIGS. 11 and 12, the flexible band 18 is positionedwithin the band passage 168 of the tensioning assembly 60. To positionthe flexible band 18 within the band passage 168 of the tensioningassembly 60, the band locking lever 74 is rotated to the unlockedconfiguration to move the outer locking member 76 away from the innerlocking member 78. With the band locking lever 74 in the unlockedconfiguration, the flexible band 18 is positioned in the band passage168 and between the locking surfaces 184, 189 (FIGS. 3 and 4) of theinner and outer locking members 76, 78, respectively. The flexible band18 may abut the first support arm 160 a to backstop the flexible band 18within the band passage 168. The flexible band 18 may also be positionedin the band recess 38 of the tensioning screw securement arm 37 of thedistal portion 30. The flexible band 18 may be positioned within theband passage 168 with the tensioning assembly 60 positioned anywherealong the tensioning screw 90 between its proximal position (FIG. 11)and its distal position (FIG. 12).

With the flexible band 18 positioned within the band passage 168, thetensioning assembly 60 is moved to its distal position as shown in FIG.12. The tensioning assembly 60 may be moved to its distal position byrotating the tensioning screw 90 until the tensioning assembly 60 abutsthe tensioning screw securement arm 37. Alternatively, the tensioningassembly 60 may be moved to its distal position by depressing the button64 to the depressed position, as detailed above, to disengage thethreads of the second wall 153 b from the threads of the tensioningscrew 90 and sliding the tensioning assembly 60 into abutment with thetensioning screw securement arm 37 before releasing the button 64. Whenthe button 64 is released, the button biasing member 66 urges the button64 to the disengaged position such that the threads of the second wall153 b engage the threaded body 94 of the tensioning screw 90.

Referring to FIG. 13, with the flexible band 18 positioned in the bandpassage 168 and the tensioning assembly 60 in its distal position, theband locking lever 74 is rotated to the locked configuration such thatthe outer locking member 76 is moved towards the inner locking member78. As the outer locking member 76 is moved towards the inner lockingmember 78, the locking surfaces 184, 189 (FIGS. 3 and 4) of the innerand outer locking members 76, 78, respectively, engage the flexible band18 to fix the flexible band 18 relative to the tensioning assembly 60.The ends 18 a of the flexible band 18 are pulled by hand until slack orexcess material of the flexible band 18 is drawn through the slot of theclamp 12 before the band locking lever 74 is rotated to the lockedconfiguration. Additionally, the ends 18 a of the flexible band 18 maybe pulled by hand to tension the flexible band 18 about the bony elementVB before the band locking lever 74 is rotated to the lockedconfiguration.

With reference to FIG. 14, with the flexible band 18 fixed within theband locking mechanism 70 of the tensioning assembly 60, the tensioningscrew 90 is rotated to translate the tensioning assembly 60 towards itsproximal position. As the tensioning assembly 60 is translated towardsits proximal position, the flexible band 18 is drawn through the slot ofthe clamp 12 and is tensioned about a bony element VB. The tensioningassembly 60 is translated until the flexible band 18 is reduced andfully tensioned about the bony element VB.

Referring to FIG. 15, it is contemplated that the flexible band 18 mayneed to be tensioned more than tension applied to the flexible band 18by a single translation of the tensioning assembly 60 from its distalposition to its proximal position such that multiple translations of thetensioning assembly 60 are required. In such instances, the tool 200 isinserted through the tool passage 34 a of the distal portion 30 toengage a band set screw 15 of the clamp 12 when the tensioning assembly60 is in its proximal position. The tool 200 is then rotated to rotatethe band set screw 15 to at least partially fix the flexible band 18within the slot of the clamp 12. With the flexible band 18 at leastpartially fixed, the band locking lever 74 is rotated to the unlockedconfiguration and the tensioning assembly 60 is translated to itsproximal position. As detailed above, the tensioning assembly 60 may betranslated by rotating the tensioning screw 90 or by depressing thebutton 64. With the tensioning assembly 60 in its distal position, theband locking lever 74 is rotated to the locked configuration to fix theflexible band 18 to the tensioning assembly 60. With the flexible band18 fixed to the tensioning assembly 60, the tool 200 is rotated torotate the band set screw 15 such that the flexible band 18 is free toslide within the slot of the clamp 12. The tensioning screw 90 is thenrotated again to translate the tensioning assembly 60 towards itsproximal position to draw the flexible band 18 through the slot of theclamp to reduce and tension the flexible band 18 about the bony elementVB. This process is repeated until the flexible band 18 is fully reducedand tensioned about the bony element VB with a desired amount oftension.

When the flexible band 18 is fully tensioned, the tool 200 is insertedthrough the tool opening 34 b of the distal portion to engage the rodset screw 13 of the clamp 12 as shown in FIG. 11. The tool 200 isrotated to fully tighten the rod set screw 13 to the rod 19 to fix theclamp 12 to the rod 19. The tool 200 is then removed from the toolopening 34 b and inserted through the tool opening 34 a to engage theband set screw 15. The tool 200 is then rotated to fully tighten theband set screw 15 to fix the flexible band 18 within the slot of theclamp 12.

Referring to FIG. 16, with the clamp 12 fixed to the rod 19 and theflexible band 18 fixed within the slot of the clamp 12, the flexibleband 18 is cut to length adjacent the clamp 12. It is contemplated thatthe flexible band 18 is cut in a range of about 0.1 cm to about 2.0 cmfrom the clamp 12 (e.g., 1.0 cm). It is further contemplated that theband locking lever 74 may be rotated to the unlocked configurationand/or the tensioning assembly 60 may be moved towards its distalposition, by rotation of the tensioning screw 90 and/or depressing thebutton 64 as detailed above, to remove tension from the flexible band 18after the band set screw 15 fixes the flexible band 18 within the slotand before the flexible band 18 is cut to length.

When the flexible band 18 is cut to length, the securement screw 80 isrotated to translate the securement arm 40 to its proximal position suchthat the securement fingers 46 are withdrawn from over the rod recess 17of the clamp 12. As detailed above, as the securement arm 40 reaches itsproximal position, the walls defining the lock cam channel 48 engagelock cam pin 54 to pivot the clamp lock 50 to the unsecuredconfiguration. With the securement arm 40 in its proximal position, theclamp 12 is released from the clamp receiver 32 of the distal portion 30of the inserter 10.

While several embodiments of the disclosure have been shown in thedrawings, it is not intended that the disclosure be limited thereto, asit is intended that the disclosure be as broad in scope as the art willallow and that the specification be read likewise. Any combination ofthe above embodiments is also envisioned and is within the scope of theappended claims. Therefore, the above description should not beconstrued as limiting, but merely as exemplifications of particularembodiments. Those skilled in the art will envision other modificationswithin the scope of the claims appended hereto.

What is claimed:
 1. A surgical instrument comprising: a body defining alongitudinal axis and having a proximal portion and a distal portion,the distal portion defining a recess; a securement arm coupled to thebody and translatable along the body in a direction parallel to thelongitudinal axis between a first position and a second position; aclamp lock pivotally coupled to the distal portion of the body, theclamp lock pivotable between a secured configuration and an unsecuredconfiguration; and a tensioning assembly translatable in the directionparallel to the longitudinal axis between a proximal position and adistal position, the tensioning assembly configured to draw a flexibleband to tension the flexible band about a bony element.
 2. The surgicalinstrument according to claim 1, further comprising a securement screwpassing through a securement opening defined in the proximal portion ofthe body and rotatably coupled to a distal end of the securement arm,the securement screw configured to translate the securement arm betweenits first and second positions.
 3. The surgical instrument according toclaim 2, wherein the securement screw includes a threaded body and wallsdefining the securement opening includes threads, the threaded body ofthe securement screw engaging the threads of the securement opening suchthat the securement arm translates in the direction parallel to thelongitudinal axis in response to rotation of the securement screw. 4.The surgical instrument according to claim 1, wherein the securement armincludes securement fingers defining a passage therebetween, the distalportion of the body positioned within the passage.
 5. The surgicalinstrument according to claim 1, wherein the clamp lock includes asecurement tab positioned on one end and defines a lock cam opening theother end, the clamp lock defining a pivot pin opening between thesecurement tab and the lock cam opening.
 6. The surgical instrumentaccording to claim 5, wherein the pivot pin opening receives a pivot pinthat is fixed to the distal portion of the body such that the clamp lockis pivotable about the pivot pin.
 7. The surgical instrument accordingto claim 5, wherein the securement tab is configured to engage a notchdefined by a clamp to secure the clamp within the recess defined in thedistal portion of the body.
 8. The surgical instrument according toclaim 5, wherein the lock cam opening receives a lock cam pin, andwherein the securement arm includes securement fingers that each definea lock cam channel, the lock cam pin disposed within the lock camchannel of each of the securement fingers.
 9. The surgical instrumentaccording to claim 8, wherein in the first position of the securementarm, the walls defining the lock cam channels engage the lock cam pin topivot the clamp lock to its unsecured configuration, and wherein in thesecond position of the securement arm, the walls defining the lock camchannels engage the lock cam pin to secure the clamp lock in its securedconfiguration.
 10. The surgical instrument according to claim 9, whereinthe securement arm has an intermediate position between its first andsecond positions such that the clamp lock is pivotable between itssecured and unsecured configurations.
 11. The surgical instrumentaccording to claim 1, further comprising a tensioning screw passingthrough a tensioning opening defined in the proximal portion of the bodyand passing through a tensioning body of the tensioning assembly, thetensioning screw configured to translate the tensioning assembly betweenthe proximal and distal positions.
 12. The surgical instrument accordingto claim 11, wherein the distal portion of the body includes atensioning screw support arm that extends perpendicular to thelongitudinal axis and defines a tensioning screw securement opening thatrotatably receives a distal end of the tensioning screw.
 13. Thesurgical instrument according to claim 11, wherein the tensioningassembly includes a button that defines a tensioning screw passage thatreceives a threaded body of the tensioning screw therein, the tensioningscrew passage defined by a first wall having a smooth surface and asecond wall including threads.
 14. The surgical instrument according toclaim 13, wherein the button has a disengaged position wherein thesecond wall is engaged with threaded body of the tensioning screw suchthat the tensioning assembly translates in the direction parallel to thelongitudinal axis in response to rotation of the tensioning screw, andwherein the button has a depressed position wherein the second wall isdisengaged from the threaded body of the tensioning screw such that thetensioning assembly is freely translatable over the threaded bodyparallel to the longitudinal axis irrespective of rotation of thetensioning screw.
 15. The surgical instrument according to claim 1,further comprising a band locking mechanism positioned on the tensioningassembly, the band locking mechanism configured to fix a flexible bandto the tensioning assembly.
 16. The surgical instrument according toclaim 15, wherein the tensioning assembly includes a first support armand a second support arm, each of the first and second support armsdefining a pin opening that receives an end of a flexible band lockpivot pin, and wherein the band locking mechanism includes a lockinglever pivotally supported about the flexible band lock pivot pin. 17.The surgical instrument according to claim 16, wherein the band lockingmechanism includes an inner locking member and an outer locking member,the inner locking member pivotally coupled to a tensioning body of thetensioning assembly and including an inner locking surface facing theouter locking member, the outer locking member including tabs connectedby a connector, each of the tabs defines a flexible band pin lockopening that slidably receives the band locking pin.
 18. The surgicalinstrument according to claim 17, wherein the tabs define opposingcamming recesses that receive cam bosses defined on the locking lever,the locking lever pivotable between an unlocked configuration and alocked configuration such that as the locking lever is pivoted towardsthe locked configuration, the cam bosses engage the tabs to move anouter locking surface disposed on the outer locking member towards theinner locking surface, the inner and outer locking surfaces defining aband passage therebetween and configured to fix a flexible band withinthe band passage when the locking lever is in its locked configuration.19. The surgical instrument according to claim 1, wherein the tensioningassembly is configured to draw the flexible band through a clamp securedin the recess of the distal portion defined by the distal portion of thebody.